IV Acetaminophen in Children Undergoing Palatoplasty

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This project is being used to assess the utility of intravenous acetaminophen in the pediatric population undergoing palate repairs. This study is a prospective randomized double blinded placebo controlled study. The investigators will have two arms, one group of patients will receive intravenous acetaminophen and one group that will receive a placebo at a total of four doses over 24 hours. The results of this study may affect the intraoperative anesthetic management as well as post-operative surgical management of this specific patient population. The goal is to determine the benefit of adding a non-opioid analgesic and hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia care unit as well as during the post-operative stay.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• ASA physical status I or II

• Presenting for repair of palatoplasty with Drs. Kirschner or Pearson

Exclusion Criteria:

• ASA physical status > II

• Underlying Syndrome

• Significant co-morbid diseases (cardiac, pulmonary, neurological disease)

• Patients having concomitant procedures (tonsillectomy, adenoidectomy, etc.)